Prediction of therapy response and treatment outcomes in early course of schizophrenia. Subproject D1_AP2 of the research network ESPRIT (Enhancing Schizophrenia Prevention and Recovery through Innovative Treatments)

Prediction of therapy response and treatment outcomes in early course of schizophrenia. Subproject D1_AP2 of the research network ESPRIT (Enhancing Schizophrenia Prevention and Recovery through Innovative Treatments) - ESPRIT_D1_AP2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010936

Enrollment

600

Registered

2016-08-16

Start date

2016-08-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM IV-TR:295.10-30, 295.90: Schizophrenia High Risc State of transmission to psychosis

Interventions

Group 1: In this study, the data of the four RCTs of ESPRIT are analyzed using predictoranalyses of the respective primary target variables (all-cause-discontinuation, transition to the manifest stage

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The study sample includes all patients (diagnosis: schizophrenia resp. people at high risk of developing psychosis) finalizing RCTs and clinical trials consenting to the follow-up. Key inclusion criteria: same as RCTs or clinical trials, no additional inclusion criteria for long-term follow-up

Exclusion criteria

Exclusion criteria: Key exclusion criteria: same as RCTs or clinical trials, no additional exclusion criteria for long-term follow-up.

Design outcomes

Primary

Measure	Time frame
The prediction analyses on the one hand will focus on the standardized main outcome variables of ESPRIT-studies: discontinuation, transition from at-risk to manifest stages of psychosis as criteria. On the other hand criteria used in previous (own and other) prediction studies will be used as dependent variable (criteria), e.g. treatment responses regarding symptomatology (“symptomatic remission”, “relapse”/”clinical deterioration”) meassured by the PANSS-Score or CGI-Change-Score or measures of social functioning (e.g. SOFAS). The analyzed data are measured in all 4 RCTs at baseline, after four months, six months (end of treatment) and after 12 months (Follow-Up).	—

Measure

Time frame

The prediction analyses on the one hand will focus on the standardized main outcome variables of ESPRIT-studies: discontinuation, transition from at-risk to manifest stages of psychosis as criteria. On the other hand criteria used in previous (own and other) prediction studies will be used as dependent variable (criteria), e.g. treatment responses regarding symptomatology (“symptomatic remission”, “relapse”/”clinical deterioration”) meassured by the PANSS-Score or CGI-Change-Score or measures of social functioning (e.g. SOFAS). The analyzed data are measured in all 4 RCTs at baseline, after four months, six months (end of treatment) and after 12 months (Follow-Up).

—

Secondary

Measure	Time frame
Predictors: - Duration of untreated psychosis - age at illness onset - premorbid functioning (SOFAS) - therapy adherence (SES, DAI, PATHEV) - symptoms (PANSS) - cognitive functioning (PFA; MASC; Digital symbol test, VLMT, TMT A and B, digitspan) - gender - drug abuse - type of medication - Side effects of medication (UKU) - caseness (MINI 6.0)	—

Countries

Germany

Contacts

Public ContactWolfgang Wölwer

LVR Klinikum Düsseldorf / Heinrich-Heine Universität Düsseldorf

woelwer@uni-duesseldorf.de0211-922-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026